FDA 483 - PT Solutions LLC - August 10, 2023

From August 7-10, 2023, the FDA inspected PT Solutions LLC, a medical device manufacturer of spinal plates, located at 2985 Nationwide Pkwy, Brunswick, OH. The inspection resulted in four observations documented on Form FDA 483, issued to Managing Partner Robert Bruce Dunaway.

Observation 1 noted inadequate process validation. Specifically, SOP 07.04 "Process Validation" did not ensure all manufacturing equipment (e.g., (b)(4) and (b)(4)) were adequately validated with Process Performance Qualifications (PQ). Additionally, the use of Excel for documenting Device History Records (DHRs) was not validated.

Observation 2 identified undocumented evaluation of potential suppliers and contractors. SOP 07.01 "Purchasing Controls" did not require documented assessment for Type 1 suppliers, including testing laboratories, which do not directly affect product quality, performance, or safety.

Observation 3 concerned inadequate procedures for incoming product acceptance. SOP 07.02 "Receiving, Inspection and Release of Product" did not ensure raw materials and subcomponents were adequately inspected. For example, lot (b)(4) of a component from supplier (b)(4) was used in manufacturing lot (b)(4) of spinal plates despite 10 units being out of specification for dimension (b)(4), which was not caught by PT Solutions LLC's incoming inspection, relying solely